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510(k) K250788

Definium Tempo Select by Ge Hualun Medical Systems Co. , Ltd. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2025
Date Received
March 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Ge Hualun Medical Systems Co. , Ltd.

  • K253269 — OEC One CFD (November 26, 2025)
  • K240828 — OEC One ASD (December 27, 2024)
  • K242678 — Definium Pace Select ET (October 1, 2024)
  • K231892 — Definium Pace Select (September 12, 2023)
  • K191699 — Discovery XR656 HD with VolumeRad (July 24, 2019)
  • K182626 — OEC One (November 16, 2018)
  • K173612 — Optima XR646 HD (December 11, 2017)
  • K172700 — OEC One (November 9, 2017)
  • K172869 — Discovery XR656 HD (October 20, 2017)
  • K171800 — OEC Elite MiniView (July 12, 2017)

Other clearances for product code KPR

  • K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 dete (January 20, 2026)
  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250790 — INNOVISION-DXII (August 1, 2025)
  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
  • K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (January 6, 2025)
  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)
  • K242847 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (October 23, 2024)